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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
19 November 1997 to 21 December 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(challenge concentration was not non-irritating)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Alcohols, C16-19-branched
EC Number:
297-790-4
EC Name:
Alcohols, C16-19-branched
Cas Number:
93762-74-4
IUPAC Name:
93762-74-4
Constituent 2
Reference substance name:
Alcohols, C16-C19 branched
IUPAC Name:
Alcohols, C16-C19 branched
Details on test material:
- Name of test material (as cited in study report): Development Detergent Alcohol 23731-52. Equivalent to Alcohols, C16-17, monobranched, type 2
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: alcohols, C16-C19 branched
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 23731-52
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: original container at room temperature and under nitrogen
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: 325-366 g at randomization
- Housing: individual, suspended wire-mesh cages
- Diet: PMI Feeds, Inc. Certified Guinea Pig LabDiet 5026, ad libitum
- Water: reverse osmosis-treated municipal water, ad libitum
- Acclimation period: a minimum of 5 days prior to initiation of dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 35.0-45.8
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: PEG 400 or 1:1 FCA and sterile saline
Concentration / amount:
Induction phase: 5% w/v mixture in PEG 400 or 1:1 FCA and sterile saline prepared for injection, neat material used for occlusive epicutaneous induction phase
Challenge phase: 2.5% w/v mixutre in PEG 400
Rechallenge phase: 0.5% w/v mixture in PEG 400
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: PEG 400 or 1:1 FCA and sterile saline
Concentration / amount:
Induction phase: 5% w/v mixture in PEG 400 or 1:1 FCA and sterile saline prepared for injection, neat material used for occlusive epicutaneous induction phase
Challenge phase: 2.5% w/v mixutre in PEG 400
Rechallenge phase: 0.5% w/v mixture in PEG 400
No. of animals per dose:
10 (controls), 20 (test group)
12 (range finding study)
Details on study design:
RANGE FINDING TESTS: Intradermal and topical range finding studies conducted. Guinea pigs received a total of six 0.1 ml intradermal injections in a 2 x 4 cm area on the dorsal surface. Three pairs of injections were made along the spine of each guinea pig. Each animal received one injection of 1, 3 or 5% w/v concentrations of the test material in PEG 400 and in a 1:1 FCA and sterile saline solution. For the topical range finding test, 2.5, 5, 10, 25 or 50% w/v mixtures in PEG 400, as well as the neat material, were used and administered at 0.2 ml/site under occulded chambers for 24 h. There were 3 sites/guinea pig and 4 sites/concentration. After a 24-h exposure period, the bandages were removed and the sites washed with disposable paper towels moistened with tepid tap water. The guinea pigs were observed twice daily for mortality and the application sites were evaluated at approx. 24 and 48 h after intradermal injection or patch removal and graded accordingly (see "any other information" section below). The hair was removed from the backs of the guinea pigs prior to evaluation

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 9 days
- Test groups: Test material in PEG 400 or a 1:1 mixture of FCA and sterile saline for the injection phase, neat test material for the topical phase
- Control group: PEG 400, 1:1 mixture of FCA and sterile saline, 50% w/v concentration of PEG 400 in 1:1 mixture of FCA and sterile saline
- Site: dorsal surface
- Frequency of applications: one intradermal injection exposure on day 0 and one topical exposure on day 7
- Duration: 9 days
- Concentrations: intradermal injection of 5% test material, topical application of neat test material

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 & 29
- Exposure period: 24 hours
- Test groups: test material in PEG 400 and PEG 400
- Control group: test material in PEG 400 and PEG 400
- Site: test material in PEG 400 - left flank; PEG 400 vehicle only - right flank
- Concentrations: 0.5 or 2.5%
- Evaluation (hr after challenge): 24 & 48 hours

OTHER: Sites were washed with disposable paper towels moistened with tepid water after each challenge exposure period
Challenge controls:
Control group subjected to the same induction procedure as test group but without test material; control and test groups both challenged with test material in the same way
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde (see "Any other information" section below)

Study design: in vivo (LLNA)

Statistics:
Not required

Results and discussion

Positive control results:
At challenge, the positive control material induced 3 very slight (grade +/-), 4 slight (grade 1) and 3 moderate (grade 2) reactions at the 24 h evaluation. By 48 h, 3 very slight, 5 slight and 2 moderate responses were observed. Focal eschar was noted for one site at both 24 and 48 h. The Sensitization Incidence Index was calculated to be 70% for the positive control and the Irritation Severity Indices were 1.2 and 1.1 at 24 and 48 h respectively. The positive control material was, therefore, shown to be a sensitizer under the conditions of the study, thereby demonstrating the reliability of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
14 grade 1, 4 grade 2
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: 14 grade 1, 4 grade 2.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
grade 1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: grade 1.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
grade 1
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: grade 1.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
grade 1
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: grade 1.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5% HCA
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5% HCA. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5% HCA
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5% HCA. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
8 grade 1, 2 grade 2
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 8 grade 1, 2 grade 2.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
grade 1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: grade 1.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0.5%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
grade 1
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: grade 1.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no irritation reactions
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no irritation reactions.

Any other information on results incl. tables

Since the reactions in the test group were no more intense than the response to the test material in the negative control group, the test material is not considered to be a skin sensitiser in this study. The sensitivity of the test system was demonstrated by a clear positive response to the positive control.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a reliable study, conducted to OECD guideline 406, there was no evidence of skin sensitisation in a guinea pig maximization test, under the conditions of this study. The study was performed in compliance with GLP.